NCT07542470
Comparing Outcomes in Patients Who Have Spinal Surgery Who Have No-Ice Cold and Compression Therapy Using the NICE1 Device Versus Standard of Care
Enrolling by Invitation
PHASE4Ages 18+InterventionalSupportive careSarasota Memorial Health Care SystemInvestigator-initiated
~156 participants
Updated 2026-04-21 on ClinicalTrials.gov
What's tested:ice-free cryopneumatic therapy device
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assessment of pain
Measured over For enrolled patients, a baseline pain scores will be recorded, and then daily during 7am-7pm shifts, and at 7pm-7am shifts, until the patient is discharged from the hospital, and at two weeks after the patient has been discharged from the hospital.
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesFlorida1
Study leadership
- Julie Collins, RN, BSN · PRINCIPAL_INVESTIGATOR · Sarasota Memorial Health Care System
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Patients must be 18 years or older
Are scheduled for an elective spinal surgery that includes a level 2 or above spinal fusion and/or laminectomy
Have consenting capacity and voluntarily agree to participate in the study
Exclusion
Patients under the age of 18
Are scheduled for an elective spinal surgery that includes a level 1 spinal fusion and/or laminectomy
Admitted from the ECC or a direct admission
Cold hypersensitivity or Raynaud's disease
Cryoglobulinemia or acute paroxysmal cold hemoglobinuria
Vascular impairments in the area such as that from ischemia or arteriosclerosis, diabetes, frostbite, wound injuries (with the exception of the surgical incision), and pressure sores
Kyphoplasty patients
Participants may be excluded or unenrolled from the study at the discretion of the principal investigator and/or sub-investigator based on their clinical judgment and if their health and/or safety may be impacted
What this trial measures
- Assessment of painFor enrolled patients, a baseline pain scores will be recorded, and then daily during 7am-7pm shifts, and at 7pm-7am shifts, until the patient is discharged from the hospital, and at two weeks after the patient has been discharged from the hospital.
Pain scores will be assessed among patients who receive cryopneumatic therapy using the NICE1 device and compared to pain scores of patients who received standard of care. Pain will be rated on a scale of 0-10, where 0= no pain and 10= the worst pain.
- Amount and need for opioid medication to control painAt baseline at time of enrollment in the study, daily until the patient is discharged from the hospital, typically 3 days, and then at two weeks after hospital discharge.
Opioid usage among patients who receive cryopneumatic therapy using the NICE1 device will be assessed and compared to opioid use in patients who received standard of care.